Open-Label Adhesion Performance Studies of a New Lidocaine Topical System 1.8% versus Lidocaine Patches 5% and Lidocaine Medicated Plaster 5% in Healthy Subjects

• Published in: Journal of pain research Vol. 14; pp. 513 - 526
• Main Authors: Gudin, Jeffrey, Webster, Lynn R, Greuber, Emileigh, Vought, Kip, Patel, Kalpana, Kuritzky, Louis
• Format: Journal Article
• Language: English
• Published: New Zealand Dove Medical Press Limited 01.01.2021; Taylor & Francis Ltd; Dove; Dove Medical Press
• Subjects: adhesion; Age; Bioavailability; Drug dosages; FDA approval; Labels; Lidocaine; lidocaine medicated plaster; lidocaine patch; lidocaine topical system; Narcotics; Original Research; Pain; Patient compliance; Pharmaceutical industry; Pharmaceuticals; postherpetic neuralgia; Skin; United States; United States > US; lidocaine medicated plaster; postherpetic neuralgia; adhesion; lidocaine patch; lidocaine topical system
• ISSN: 1178-7090; 1178-7090
• DOI: 10.2147/JPR.S287153

The primary objective was to evaluate adhesion performance of the lidocaine topical system 1.8% for 12 hours in healthy human subjects in three studies: as a single product (Study 1) and versus other lidocaine topical products (lidocaine patch 5% and lidocaine medicated plaster 5% [Study 2] and generic lidocaine patch 5% [Study 3]). Safety of the lidocaine topical system 1.8%, with a skin irritation focus, was a secondary objective. All three studies were open-label, randomized, Phase 1 adhesion performance studies in healthy adult volunteers (N=125). Lidocaine topical products were applied for 12 hours per test, per study arm. Adhesion of all test products was scored at 0, 3, 6, 9, and 12 hours post-application. Skin irritation was scored after product removal or when a product detached. Overall, the majority (≥75%) of subjects treated with the lidocaine topical system 1.8% demonstrated ≥90% adhesion (FDA adhesion score 0) throughout the 12-hour administration period versus 13.6% of subjects treated with lidocaine patch 5%, 15.9% of subjects treated with lidocaine medicated plaster 5%, and 0% of subjects treated with the generic lidocaine patch 5%. There were no complete detachments with the lidocaine topical system 1.8%, whereas 4.5% of lidocaine patch 5% and lidocaine medicated plaster 5% detached, and 29% of generic lidocaine patch 5% detached. Minimal skin irritation was observed with each lidocaine topical product. Across three studies, lidocaine topical system 1.8% demonstrated superior adhesion performance versus the three other products tested. Skin irritation was minimal across products and studies. NCT04312750, NCT04320173, NCT04319926.